Circulating IL-6, Clusterin and Irisin in Obese Subjects

NCT04133896 | Completed

• 1 other identifier: Obesity and IR
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

evaluate the circulating levels of IL-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and their sexual dimorphism also identify the association of IL-6, clusterin and irisin with insulin resistance.

Conditions

Obesity

Outcome Measures

Primary Outcomes (5)

• insulin resistance

  by homeostasis insulin resistance index (fasting insulin (μIU/ml) times fasting glucose (mg/L) divided by 405 )

  18 months

• IL- 6

  blood level of IL-6

  18 Months

• Clusterin

  blood level of Clusterin

  18 Months

• Irisin

  blood level of Irisin

  18 Months

• Lipid profile

  Plasma triglycerides and total cholesterol were measured by enzymatic colorimetric method. High-density lipoprotein cholesterol (HDL-C) was measured by precipitation method. Low density lipoprotein cholesterol (LDL-C) was calculated using the Friedewald formula

  18 Months

Study Arms (8)

Group 1 Male

group 1 (22 lean men),

Diagnostic Test: IL-6, Clusterin, Irisin Level

Group 2 Male

group 2 (22 class I obese men),

Diagnostic Test: IL-6, Clusterin, Irisin Level

Group 3 Male

group 3 (22class II obese men),

Diagnostic Test: IL-6, Clusterin, Irisin Level

Group 4 Male

group 4 (22 class III obese men).

Diagnostic Test: IL-6, Clusterin, Irisin Level

Group 1 Female

group 1 (22 lean women),

Diagnostic Test: IL-6, Clusterin, Irisin Level

Group 2 Female

group 2 (22 class I obese women),

Diagnostic Test: IL-6, Clusterin, Irisin Level

Group 3 Female

group 3 (22 class II obese women),

Diagnostic Test: IL-6, Clusterin, Irisin Level

Group 4 Female

group 4 (22 class III obese women).

Diagnostic Test: IL-6, Clusterin, Irisin Level

Interventions

IL-6, Clusterin, Irisin Level DIAGNOSTIC_TEST

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Group 1 Female; Group 1 Male; Group 2 Female; Group 2 Male; Group 3 Female; Group 3 Male; Group 4 Female; Group 4 Male

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects included in the study were classified according to their sex into two main group the male group and the female group. The male group contained 88 men which subdivided according to the BMI into the following groups; group 1 (22 lean men), group 2 (22 class I obese men), group 3 (22class II obese men), and group 4 (22 class III obese men). The female group contained 88 adult women which sub-classified according to BMI into the following subgroups; group 1 (22 lean women), group 2 (22 class I obese women), group 3 (22 class II obese women), and group 4 (22 class III obese women).

You may qualify if:

• Healthy Female and Male
• Age matched adult non-diabetic non-smoker males and females'

You may not qualify if:

• smokers, subjects with a history of diabetes mellitus, liver, renal, thyroid, inflammatory diseases, and females on contraceptives pills. Patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, anti-hyperlipidemics, non-selective beta blockers, thiazides, etc.) and subjects with organic causes of obesity were also excluded from this study.

Sponsors & Collaborators

• Rehab Werida: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (3)

• Gouni-Berthold I, Berthold HK, Huh JY, Berman R, Spenrath N, Krone W, Mantzoros CS. Effects of lipid-lowering drugs on irisin in human subjects in vivo and in human skeletal muscle cells ex vivo. PLoS One. 2013 Sep 2;8(9):e72858. doi: 10.1371/journal.pone.0072858. eCollection 2013.

  PMID: 24023786 RESULT

• Baralla A, Sotgiu E, Deiana M, Pasella S, Pinna S, Mannu A, Canu E, Sotgiu G, Ganau A, Zinellu A, Sotgia S, Carru C, Deiana L. Plasma Clusterin and Lipid Profile: A Link with Aging and Cardiovascular Diseases in a Population with a Consistent Number of Centenarians. PLoS One. 2015 Jun 15;10(6):e0128029. doi: 10.1371/journal.pone.0128029. eCollection 2015.

  PMID: 26076476 RESULT

• van Greevenbroek MM, Schalkwijk CG, Stehouwer CD. Obesity-associated low-grade inflammation in type 2 diabetes mellitus: causes and consequences. Neth J Med. 2013 May;71(4):174-87.

  PMID: 23723111 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rehab H Werida, Lecturer

  Damanhour University, Faculty of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Pharmacy Lecturer

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 21, 2019
• Study Start: February 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 30, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)